Drug-device combination products available

Sweet, B., Schwemm, A., Parsons, D., 2011. Review of the processes for FDA oversight of drugs, medical devices, and combination products. J. Manag. Care Pharm. 17 (1), 40-50. Available at http //www.ncbi.nhn.nih.gov/pubmed/21204589 (accessed 05.01.16). 

The device is available as a marketed product and the drug that is to be inserted into the pen-injector device is purchased by the patient separately. Here the combination is undertaken by the patient, not by the manufacturer. 

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